A Safety, Tolerability and Preliminary Efficacy Study of DRM01B Topical Gel

Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Olumacostat Glasaretil Gel, 7.5%; Other: Olumacostat Glasaretil Gel, Vehicle

• Registration Number: NCT01936324
• Lead Sponsor: Dermira, Inc.

Brief Summary

This is a Phase 1/2a study.

The purpose of Phase 1 was to evaluate the safety and tolerability of DRM01B Topical Gel in 6 healthy volunteers.

The purpose of Phase 2a was to assess the safety, tolerability and preliminary efficacy of DRM01B Topical Gel compared to vehicle in subjects with acne vulgaris on the face.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-05
• Study First Posted: 2013-09-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2019-01-31
• Results First Submitted QC: 2019-01-31
• Results First Posted: 2019-05-10
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-16
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 1	Olumacostat Glasaretil Gel, 7.5%	Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers
Phase 2a	Olumacostat Glasaretil Gel, 7.5%	Olumacostat Glasaretil Gel, 7.5%, or Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Phase 2a	Olumacostat Glasaretil Gel, Vehicle	Olumacostat Glasaretil Gel, 7.5%, or Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks

Primary Outcome Measures

Name	Time	Method
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 in Phase 2a	Baseline and Week 12	Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 in Phase 2a
Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 in Phase 2a	Baseline and Week 12	Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12 in Phase 2a
Percentage of Subjects Who Achieved ≥ 2-grade Improvement in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 in Phase 2a	Baseline and Week 12	Percentage of subjects who achieved ≥ 2-grade improvement in the investigator global assessment of acne (IGA) from baseline to Week 12 in Phase 2a; Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions; 1. - Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion; 2. - Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions); 3. - Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion; 4. - Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions

Trial Locations

Locations (12)

Innovaderm Research, Inc; 🇨🇦 Montreal, Quebec, Canada

Centre de Recherche Dermetologique du Quebec Metropolitain (CRDQ); 🇨🇦 Quebec, Canada

K. Papp Clinical Research Inc.; 🇨🇦 Waterloo, Ontario, Canada

Siena Medical Research; 🇨🇦 Montreal, Quebec, Canada

Guildford Dermatology Specialist Inc; 🇨🇦 Surrey, British Columbia, Canada

Lynderm Research Inc; 🇨🇦 Markham, Ontario, Canada

Ultranova Skincare; 🇨🇦 Barrie, Ontario, Canada

Institute of Cosmetic & Laser Surgery; 🇨🇦 Oakville, Ontario, Canada

Skin Centre for Dermatology; 🇨🇦 Peterborough, Ontario, Canada

The Centre for Dermatology; 🇨🇦 Richmond Hill, Ontario, Canada

Research Toronto; 🇨🇦 Toronto, Ontario, Canada

Windsor Clinical Research, Inc.; 🇨🇦 Windsor, Ontario, Canada